Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022257
Company: CHEPLAPHARM
Company: CHEPLAPHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VALCYTE | VALGANCICLOVIR HYDROCHLORIDE | 50MG/ML | FOR SOLUTION;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/23/2021 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021304.s17_22257s12lbl.pdf | |
| 11/24/2020 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021304s016,022257s011lbl.pdf | |
| 10/21/2020 | SUPPL-10 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022257Orig1s010,021304Orig1s015Lbl.pdf | |
| 08/02/2018 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022257s009,021304s014lbl.pdf | |
| 08/02/2018 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022257s009,021304s014lbl.pdf | |
| 06/22/2017 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021304s012,022257s007lbl.pdf | |
| 06/22/2017 | SUPPL-7 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021304s012,022257s007lbl.pdf | |
| 04/23/2015 | SUPPL-5 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022257s005,021304s011lbl.pdf | |
| 03/28/2013 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021304s010,022257s004lbl.pdf | |
| 08/05/2010 | SUPPL-3 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021304s008,022257s003lbl.pdf | |
| 08/28/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021304s007,022257s000lbl.pdf |